A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)

Sponsor: Amgen

Sponsor score: 60

ClinicalTrials ID:NCT07005128

This clinical trial evaluates the efficacy of adding tarlatamab to a regimen of durvalumab, carboplatin, and etoposide in patients with extensive-stage small-cell lung cancer. Eligible participants must be adults with documented ES-SCLC, measurable disease, and a life expectancy of at least 12 weeks. All drugs are administered via IV infusion.

Patient Parameters

Program Overview

The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).

Eligibility Criteria

Inclusion Criteria

  • Participant has provided informed consent before initiation of any study-specific activities/procedures.
  • Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.
  • Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC [T any, N any, M1 a/b/c]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
  • Measurable disease as defined per RECIST 1.1.
  • Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment.
  • Minimum life expectancy ≥ 12 weeks.

Exclusion Criteria

  • Participants can have no history of other malignancy in the last 2 years.
  • Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
  • They will have no history of severe or life-threatening events to immune-mediated therapy.
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
  • They will have no active autoimmune or inflammatory disorders.
  • Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection.
  • Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis.
  • History of solid organ transplant.
  • They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.

Locations

FACILITYZIPCITYSTATE
Saint Bernards Medical Center72401JonesboroArkansas
University of Illinois Chicago60612ChicagoIllinois
Cancer Center of Kansas, Heritage Plaza Medical Building67214WichitaKansas
Allina Health System dba Allina Health Cancer Institute55407MinneapolisMinnesota
Kaiser Permanente Medical Center97227PortlandOregon
Baptist Cancer Center38120MemphisTennessee
West Virginia University Health Sciences Center26506MorgantownWest Virginia

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